Corrective Actions - Specifically closing out and verifying effectiveness

D

David Mullins

#11
Hmmm. I worked with an organisation that had 23 locations, 160 employees, and generated 600 CARs a year. This quantum is not managable unless you have a very good system for dealing with them.
CLOSE OUT, is a critical problem. I had eleven people who had the additional job of being internal auditors. Audits were conducted at each site every 6 months, and all CARs that were OPEN during that period were reviewed, and closed out by the auditors in their reports, or noted as not fully implemented, or whatever.
It was the only way I could close out the things, except where the preventive actions related to revised documentation, or some other thing that I could witness without driving all over the place.

The particular CAR system included OHS incidents and hazards, customer complaints, nonconformances, improvements, security breaches, etc., etc.

For the managers I focussed on them adopting an empathetic apporach - if you wrote this CAR, would you be satisfied with the responses and actions?

In the circumstance where your auditor is coming, and you can't find any other means to motivate people, steer the auditor to focus on the problems you are experiencing. He/She will raise a NCR and hopefully this will spark the necessary crisis meeting and actions. It also serves to steer auditors away from anything else you don't want to deal with until you get the time!

Let the challenge motivate you, don't throw in the towel just yet - if I used that approach, I'd spend all my time fishing, golfing, surfing and sunbathing.

You must get executive buy-in. The CAR problems may just be a symptom of a far worse disease!

------------------
 
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Kevin Mader

One of THE Original Covers!
Staff member
Admin
#12
Originally posted by ISO GUY:
I hate to say it the owners of the company don't really care about conforming to the standards, they just want the Certificate that says we are ISO certified. They see QA as an expense because " We do not make any money for the company", they don't understand that we are trying to save the company money...

...As far as pointing out the problems in our CAR system ( I don't want to get fired) I will let the Registrar find out for themselves. Well now that I sund like I am not making any sense at all I am out of here.
To your post (I hope I got the quote thing right):

It sounds like your management doesn't know how the ISO tool benefits their organization. Why is this? What are their individual theories based on? What are their expectations? Do you have any of these answers?

I suppose many organizations try for ISO because they want to "keep up with the Jones's." Get the certificate, mount it on the wall for all to see, let Marketing run to trade shows and wave flags of success. But does it have to be this way?

People need education and understanding about things. Superficial thinking is a serious disease in this country, as well as many other places in the world. What have we done to cure this disease? I think that Quality folks need an extra measure of patience. People need time to grasp what is important and we must present it in a way people will understand.

My thoughts: We need to understand the problems. Next, we theory. We must know the inputs and learn to control them. We must continually work to improve the process.

The questions I started with are to begin the process of understanding why management is content on playing lipservice to ISO. Maybe it was something they read and didn't agree with? Maybe Scapegoat 1 or 2 painted an awful picture, or one they can't understand? What can you do to change that?

If you gain a better understanding of the problem(s), you may be able to address them successfully, thus increasing the likelihood that they will return the favor by helping you to address the issues with your CARs. Collaboration is necessary.

You aren't alone ISOGUY. The war is not lost! If you let the registrar discover the CAR problem, you may risk what you fear of losing.

Regards,

Kevin
 
A

Aaron Lupo

#13
Well that is true. I have't given up it is just very frustrating. There are many many problems with the Company I work for. I hate to say it the owners of the company don't really care about conforming to the standards, they just want the Certificate that says we are ISO certified. They see QA as an expense because " We do not make any money for the company", they don't understand that we are trying to save the company money. When ISO was first suggested I would say about 5 years ago, the person who held the job I have now really set a great system up (it was meet with great resistance and still is LOL) but as in life all good things must come to an end, and he moved on to bigger and better things. Then came the nightmare of an ISO Coordinator. He didn't do the job very well and the system went backwards instead of forward, so then I walk in and now I am stuck with, department managers having a bad taste in their mouths from this person. I am trying to rectify this situation by letting everyone know that I am here to help them not point out non-conformances and lord it over them (as was happening over the last 2 years). I think it will take some time to get them to understand that I am on their team and not against them, I know it will take some time and banging my head against the wall, but it will happen( I hope). As far as pointing out the problems in our CAR system ( I don't want to get fired) I will let the Registrar find out for themselves. Well now that I sund like I am not making any sense at all I am out of here.
 
S

Spaceman Spiff

#14
I am in need of some assistance... we have several low volume products that goes to distributors. Periodically we get rejection of 1 piece. Since the distributors are all jumping on the ISO bandwagon, I am getting requests for corrective action based on a single returned unit, some may be a year old (our warranty period) and others may have seen field use. It is very difficult to determine the exact root cause of the problem (especially if they've been in service). I hate to use the old "informed the operators" as a boilerplate answer. Anyone out there have any comments?
 
S

Spaceman Spiff

#15
In almost all cases, we do get rejects back (customers do not receive credits unless parts are sent). We perform return analysis on all returned parts. I've considered the threashold idea, but customer are requesting a formal written CAR regardless of return sample size in order to fulfill their ISO obligations.

My delimma is now I have a formal request for CA with only one actual part. I would love to respond with a canned CAR that says you are wasting my time... but the customer is "always" right, right?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#16
Do your analysis. If you cannot determine the cause of the failure I would state the same in a letter to the customer. If you know what the failure mode was,, check your database. If it is not a recurrent problem I would state so and state that it has been determined that no corrective action is necessary (here is your threshold) - that as of this point you consider the failure mode to be a 'freak' failure as indicated by no other record of the same failure mode. Instead of a letter have a corrective action form and complete only the appropriate fields.

The key is to be able to say what is a repetition and what is not. Now - this is all and well for me to say, so I will put in a cavat. Let's say you make air bags. A freak failure is not well tolerated by the public or government - thus the product makes a difference.

No - the customer is not always right. You know that and I know that.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#17
Originally posted by Spaceman Spiff:

Periodically we get rejection of 1 piece. Since the distributors are all jumping on the ISO bandwagon, I am getting requests for corrective action based on a single returned unit, some may be a year old (our warranty period) and others may have seen field use. It is very difficult to determine the exact root cause of the problem (especially if they've been in service). I hate to use the old "informed the operators" as a boilerplate answer. Anyone out there have any comments?
My first question would be what do you normally do with returned units?

One thing to consider --> You have to set some threshold where you do not react.

If you do not get the unit, have a canned letter which states that without the unit no investigation can proceed.
 
A

AJPaton

#18
Question-how can we relate control of non-conforming product to the corrective/preventive action clause of ISO.
We have a non-conforming product system to capture all defects and raise awareness with both operators and supervisors.
This would seem to be "corrective or preventive action taken to eliminate the causes of actual...nonconformities"
How can this be captured in a more general corrective and preventive action system.

Thanks,
 
J

Jim Biz

#19
AJ -- As I understand it you may wish to refocus on the "actions taken shall be to the degree appropriate to the maginitude and "commesurate with the risks involved"wording. 4.41.1

That's at least where we relate 4.13 Nonconforming product control to - 4.14 Corrective action (nonconforming product occurances recorded under 4.13 need to be placed in the correction AND/OR preventative system(S)If the Volume/Cost/ or potential current or future risk of reoccurance involved is "significant" enough for corrective action to be warranted...

I have in fact reported to our customers "at appropriate times" that the single occurance appears as an isolated situation and no further action is planned "until/unless" the risk involved becomes a costworthy or a risk worthy issue.

I have seen closure criteria mechanisims that allow closing single or low level nonconformance items using a time/delivery standard (for example only - 500 pcs delivered over a three month period with no further occurances would allow one to close becsuse that single or low level defect volume was a "freak" "flyer" etc. that in reality does not need documented correction.

However..nothing precludes re-opening the issue if future occurances of the same defect occur.
Regards
Jim
 
A

AJPaton

#20
Thanks Jim,
Just a further clarification, most of our non-conformances are internally generated. Since we do combination custom/standard work, any problem has to be resolved before the job can ship. (Safety concerns paramount.)
Do these problem solutions get recorded in the Corrective and/or Preventive Action system? (We tried that with bad results.)
If not, where/how should we document these intermediate solutions?

Thanks,

AJP
 
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